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ISO 13485:2016 Requirements (TPECS)

The class is not currently available.

BSI's “ISO 13485:2016 Requirements” competency-based 2-day course teaches a general understanding of the concepts of the ISO 13485:2016 standard and how the requirements impact the day-to-day operations of organizations in the Medical Device industry. An experienced instructor explains the clauses of ISO 13485:2016 in detail, providing a base for understanding the Medical Device Principles and includes auditing the requirements of the standard. Students learn by participating in group exercises and in-depth discussions.

This course covers Exemplar Global TPECS MD - Medical Device Systems Competency Unit whose outcomes are certified by Exemplar Global. Attendees successfully completing this course receive a Certificate of Attainment for this Exemplar Global Competency Unit.

New to TPECS?

For more information, please see our Understanding the TPECS Course Structure page.

Learning Objectives

  • Understand the requirements of the ISO 13485:2016 standard
  • Learn the fundamentals of Quality Management Systems, ISO 9000 / 13485 Standards
  • Auditing to requirements
  • How to identify nonconformities
  • Purpose and content of an audit report
  • Understand Medical Device Regulatory Requirements compliance framework

Course Materials

Students receive comprehensive course manuals with reference materials.

Who Should Attend

  • Any individual requiring a working knowledge and understanding of ISO 13485:2016 standard
  • Medical Professionals/Consultants
  • Presidents/Vice Presidents/CEOs
  • ISO Coordinators/Management Representatives
  • Engineers
  • Supervisors
  • Laboratory quality professionals
  • Accredited auditors requiring the competency to audit Medical Device Systems

Prerequisites

A prior review of the ISO 13485:2016 standard is suggested for this course. 

Class Logistics

There is a test at the end of Day 2 of this course. Detailed exam instructions will be provided. A Certificate of Attainment in the MD competency unit will be provided for students who are deemed “Competent” for the MD competency unit. Certificates of attendance are provided to those who do not pass the competency test, and students will be given the opportunity to retake the test.

Upcoming Course Dates

Start/End Date and Time Location Fee Enroll
  • May 01, 2018 8:00 AM - 5:30 PM
  • May 02, 2018 8:00 AM - 6:30 PM
San Diego, CA
Holiday Inn Expresss & Suites SAn Diego-Sorrento Valley
5925 Lusk Blvd,
San Diego 92121
858-731-0100
View Location Website
USD $1295.00Enroll
  • May 01, 2018 8:00 AM - 5:30 PM
  • May 02, 2018 8:00 AM - 6:30 PM
Chicago, IL
SpringHill Suites Chicago O'Hare
8101 Higgins Road
Chicago, IL 60631
United States
773-867-0000map this location
USD $1295.00Enroll
  • May 07, 2018 8:00 AM - 5:30 PM
  • May 08, 2018 8:00 AM - 6:30 PM
Raleigh, NC
DoubleTree by Hilton Hotel Raleigh - Cary
500 Caitboo Avenue
Cary, NC 27518
United States
919-239-4777
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USD $1295.00Enroll
  • May 14, 2018 8:00 AM - 5:30 PM
  • May 15, 2018 8:00 AM - 6:30 PM
San José, CA
Biltmore Hotel and Suites
2151 Laurelwood Road
Santa Clara, CA 95054
United States
408/988-8411
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USD $1295.00Enroll
  • May 14, 2018 8:00 AM - 5:30 PM
  • May 15, 2018 8:00 AM - 6:30 PM
Minneapolis, MN
DoubleTree by Hilton-Minneapolis North
2200 Freeway Boulevard
Minneapolis, MN 55430
United States
(763) 566-8000
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USD $1295.00Enroll
  • May 21, 2018 8:00 AM - 5:30 PM
  • May 22, 2018 8:00 AM - 6:30 PM
Boston, MA
DoubleTree by Hilton Hotel Boston - Downtown
821 Washington Street
Boston, MA 02111
United States
617.956.7900
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USD $1295.00Enroll
  • May 21, 2018 8:00 AM - 5:30 PM
  • May 22, 2018 8:00 AM - 6:30 PM
Memphis, TNUSD $1295.00Enroll
  • Jun 04, 2018 8:00 AM - 5:30 PM
  • Jun 05, 2018 8:00 AM - 6:30 PM
Atlanta, GAUSD $1295.00Enroll
  • Jun 11, 2018 8:00 AM - 5:30 PM
  • Jun 12, 2018 8:00 AM - 6:30 PM
Seattle, WA
Crowne Plaza Seattle Downtown
1113 6th Avenue
Seattle, WA 98101
United States
(206) 464-1980
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USD $1295.00Enroll
  • Jun 19, 2018 8:00 AM - 5:30 PM
  • Jun 20, 2018 8:00 AM - 6:30 PM
Orlando, FL
Crowne Plaza Orlando Universal
7800 Universal Blvd
Orlando, FL 32819
United States
407-355-0550map this location
USD $1195.00*Enroll
  • Jun 25, 2018 8:00 AM - 5:30 PM
  • Jun 26, 2018 8:00 AM - 6:30 PM
Princeton, NJ
Courtyard by Marriott Princeton
3815 U.S. Highway 1
@ Mapleton Princeton
Princeton, NJ 08540
United States
(609)436-8964
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USD $1195.00*Enroll
  • Jul 16, 2018 8:00 AM - 5:30 PM
  • Jul 17, 2018 8:00 AM - 6:30 PM
San José, CAUSD $1195.00*Enroll
  • Jul 23, 2018 8:00 AM - 5:30 PM
  • Jul 24, 2018 8:00 AM - 6:30 PM
Atlanta, GAUSD $1195.00*Enroll
  • Jul 23, 2018 8:00 AM - 5:30 PM
  • Jul 24, 2018 8:00 AM - 6:30 PM
Minneapolis, MNUSD $1195.00*Enroll
  • Aug 06, 2018 8:00 AM - 5:30 PM
  • Aug 07, 2018 8:00 AM - 6:30 PM
Chicago, ILUSD $1195.00*Enroll
  • Aug 06, 2018 8:00 AM - 5:30 PM
  • Aug 07, 2018 8:00 AM - 6:30 PM
Memphis, TNUSD $1195.00*Enroll
  • Aug 13, 2018 8:00 AM - 5:30 PM
  • Aug 14, 2018 8:00 AM - 6:30 PM
Boston, MAUSD $1195.00*Enroll
  • Aug 20, 2018 8:00 AM - 5:30 PM
  • Aug 21, 2018 8:00 AM - 6:30 PM
San José, CAUSD $1195.00*Enroll
  • Aug 27, 2018 8:00 AM - 5:30 PM
  • Aug 28, 2018 8:00 AM - 6:30 PM
Minneapolis, MNUSD $1195.00*Enroll
  • Aug 27, 2018 8:00 AM - 5:30 PM
  • Aug 28, 2018 8:00 AM - 6:30 PM
Princeton, NJUSD $1195.00*Enroll
  • Sep 17, 2018 8:00 AM - 5:30 PM
  • Sep 18, 2018 8:00 AM - 6:30 PM
Portland, ORUSD $1195.00*Enroll
  • Sep 17, 2018 8:00 AM - 5:30 PM
  • Sep 18, 2018 8:00 AM - 6:30 PM
Raleigh, NCUSD $1195.00*Enroll
  • Sep 24, 2018 8:00 AM - 5:30 PM
  • Sep 25, 2018 8:00 AM - 6:30 PM
Boston, MAUSD $1195.00*Enroll
  • Sep 24, 2018 8:00 AM - 5:30 PM
  • Sep 25, 2018 8:00 AM - 6:30 PM
San Diego, CAUSD $1195.00*Enroll
  • Oct 08, 2018 8:00 AM - 5:30 PM
  • Oct 09, 2018 8:00 AM - 6:30 PM
Chicago, ILUSD $1195.00*Enroll
  • Oct 15, 2018 8:00 AM - 5:30 PM
  • Oct 16, 2018 8:00 AM - 6:30 PM
Boston, MAUSD $1195.00*Enroll
  • Oct 22, 2018 8:00 AM - 5:30 PM
  • Oct 23, 2018 8:00 AM - 6:30 PM
Milwaukee, WIUSD $1195.00*Enroll
  • Oct 29, 2018 8:00 AM - 5:30 PM
  • Oct 30, 2018 8:00 AM - 6:30 PM
Atlanta, GAUSD $1195.00*Enroll
  • Nov 05, 2018 8:00 AM - 5:30 PM
  • Nov 06, 2018 8:00 AM - 6:30 PM
Memphis, TNUSD $1195.00*Enroll
  • Nov 12, 2018 8:00 AM - 5:30 PM
  • Nov 13, 2018 8:00 AM - 6:30 PM
San José, CAUSD $1195.00*Enroll
  • Nov 26, 2018 8:00 AM - 5:30 PM
  • Nov 27, 2018 8:00 AM - 6:30 PM
Princeton, NJUSD $1195.00*Enroll
  • Dec 03, 2018 8:00 AM - 5:30 PM
  • Dec 04, 2018 8:00 AM - 6:30 PM
Minneapolis, MNUSD $1195.00*Enroll
  • Dec 03, 2018 8:00 AM - 5:30 PM
  • Dec 04, 2018 8:00 AM - 6:30 PM
San Diego, CAUSD $1195.00*Enroll